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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus
A mixed method approach involving both qualitative and quantitative methods will be used.
The quantitative component will consist of a single blind, randomised controlled trial (RCT), which will explore the effects of the intervention on glycaemic control (blood sugar levels) and other secondary outcomes.
The qualitative component will consist of face to face interviews to explore the views of participants regarding acceptability and barriers affecting adherence to this intervention.
Potential participants will be informed about the study at hospital diabetes clinics, community health organisations, support groups, places of worship and General Practitioner (GP) surgeries. Recruitment is estimated to last for 9 months. Potential participants will be sent a participant information sheet (PIS) in either English or Urdu, depending on their preference. Those wishing to take part will meet the researcher at a convenient location, for eligibility screening and consent. If necessary, translation services can be arranged for those with limited English throughout the study.
Following baseline assessment, participants will be randomised to either the intervention or control group. Participants in the control group will be asked to continue their usual care and day to day physical activity routine. In addition, they will be given general information about diabetes management. Participants who wish to use the website for exercise will be provided with access at the end of all assessments.
Participants assigned to the intervention group will be asked to perform a personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks. Participants will meet the researcher face to face immediately after randomisation. During this meeting, a brief physical assessment will be undertaken and exercise goals will be discussed and agreed with participants. The researcher will then design a personalised exercise programme for each participant using the resources available on the web-based exercise website. The exercise programme prescription and progression will be in line with American Diabetes Association (ADA) and American College of Sports Medicine (ACSM) guidelines (Colberg et al. 2016). The website (www.webbasedphysio.com) will be used to deliver the intervention. This website has been modified, in collaboration with South Asians, to be culturally suitable for people of South Asian backgrounds in terms of content and language (Albalawi et al, under review). The researcher will contact participants every two weeks via telephone to encourage use of the website, ask about progress, and to deal with any technical issues that they might face while using the website. Participants will be advised to contact the researcher to request a change in their programme or if a problem arises. The researcher will make changes remotely and participants will be informed of any changes by phone or email. Participants will be asked to meet the researcher face to face to discuss progression and goals at week 6 (midway). Regardless of groups allocation, all participants will be assessed three times by a blind assessor at baseline (week=0) , after the end of the intervention (week=12) and 8 weeks after the end of the intervention (week=20).
Assessment of outcome measures will take place at convenient locations and each visit should take no more than 90 minutes. Travel expenses will be provided.
All participants will be informed that they are free to withdraw from the study at any time without being obliged to give notice or provide any explanation. Any data collected before their withdrawal will be considered in the analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based exercise programme | Experimental | Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks |
|
| Control group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based exercise programme | Behavioral | Aerobic, resistance and balance exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic control | Change in HbA1c | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipid profile (cholesterol) | Change in total cholesterol level | Baseline to 12 weeks |
| Blood lipid profile (cholesterol) | Change in total cholesterol level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna Paul, PhD | Glasgow Caledonian University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Greater Glasgow and Clyde | Glasgow | United Kingdom |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 12 weeks to 20 weeks |
| Blood lipid profile (high density lipoproteins) | Change in high density lipoprotein (HDL) level | Baseline to 12 weeks |
| Blood lipid profile (high density lipoproteins) | Change in high density lipoprotein (HDL) level | 12 weeks to 20 weeks |
| Blood lipid profile (low-density lipoproteins) | Change in low density lipoprotein (LDL) level | Baseline to 12 weeks |
| Blood lipid profile (low-density lipoproteins) | Change in low density lipoprotein (LDL) level | 12 weeks to 20 weeks |
| Blood lipid profile (triglyceride) | Change in triglyceride level | Baseline to 12 weeks |
| Blood lipid profile (triglyceride) | Change in triglyceride level | 12 weeks to 20 weeks |
| Blood pressure | Change in blood pressure result | Baseline to 12 weeks |
| Blood pressure | Change in blood pressure result | 12 weeks to 20 weeks |
| Body mass index (BMI) | Change in BMI | Baseline to 12 weeks |
| Body mass index (BMI) | Change in BMI | 12 weeks to 20 weeks |
| Waist circumference | Change in waist circumference | Baseline to 12 weeks |
| Waist circumference | Change in waist circumference | 12 weeks to 20 weeks |
| Ten metre walking test (10MWT) | Change in 10 MWT result | Baseline to 12 weeks |
| Ten metre walking test (10MWT) | Change in 10 MWT result | 12 weeks to 20 weeks |
| Timed Up and Go test | Change in Timed Up and Go test result | Baseline to 12 weeks |
| Timed Up and Go test | Change in Timed Up and Go test result | 12 weeks to 20 weeks |
| Muscle power | Change in hand grip dynamometer score | Baseline to 12 weeks |
| Muscle power | Change in hand grip dynamometer score | 12 weeks to 20 weeks |
| Quality of Life - WHO-QOL BREF score | Change in World Health Organisation Quality of Life (WHO-QOL BREF) score | Baseline to 12 weeks |
| Quality of Life - WHO-QOL BREF score | Change in World Health Organisation Quality of Life (WHO-QOL BREF) score | 12 weeks to 20 weeks |
| Adherence - exercise diary completion | Number of times exercise diary completed | 12 weeks |
| Dietary intake | Change in Food Frequency Questionnaire score | Baseline to 12 weeks |
| Dietary intake | Change in Food Frequency Questionnaire score | 12 weeks to 20 weeks |
| Change in Medication | Change in medication | Baseline to 12 weeks |
| Change in Medication | Change in medication | 12 weeks to 20 weeks |
| Glycaemic control | Change in HbA1c | 12 weeks to 20 weeks |
| D004700 | Endocrine System Diseases |